1. Field of the Invention
The present invention relates to an occluder system for the administration of enteral and/or parenteral solutions. More particularly, the present invention relates to a pinch clip occluder for use on infusion sets and the like, wherein the pinch clip occluder prevents the free-flow-flow of solution through the infusion set unless the pinch clip occluder is properly mounted in a housing or some other structure. Additionally, the present invention relates to an adapter which may be retrofit onto existing enteral feeding pumps and the like to enable the use of a pinch clip occluder to prevent free-flow conditions.
2. State of the Art
The use of infusion sets to administer solutions to patients is well known in the medical arts. Infusion sets are used for both enteral and parenteral applications. Enteral feeding pumps are used to provide patients with nutrition and medication when they are unable, for a variety of reasons, to eat normally. Parenteral (intravenous) solutions are provided to patients to ensure adequate hydration and to provide needed nutrients, minerals and medication. Often, the infusion set is placed in a free standing arrangement in which gravity forces the solution into the patient. The rate at which the solution enters the patient can be roughly controlled by various clamps, such as roller clamps, which are currently available on the market.
In many applications, it is necessary to precisely control the amount of solution which enters the patient. When this is the case, a regulating device, such as an enteral feeding pump, is placed along the infusion set to control the rate at which the solution is fed to the patient. In applications where a pump, etc., is used, the clamps used to regulate flow are typically opened to their fullest extent to prevent the clamp from interfering with the proper functioning of the pump. The clamp is opened with the expectation that the enteral feeding pump will control fluid flow through the infusion set. However, emergencies or other distractions may prevent the medical personnel from properly loading the infusion set in the enteral feeding pump. Furthermore, the infusion set may be inadvertently dislodged from the pump during operation of the pump.
When the infusion set is not properly loaded in the pump and the clamp has been opened, a situation known as free-flow often develops. The force of gravity causes the solution to flow freely into the patient unchecked by the pump or other regulating device. Under a free-flow condition, an amount of solution many times the desired dose can be supplied to the patient within a relatively short time period. This can be particularly dangerous if the solution contains potent medicines or the patient""s body is not physically strong enough to adjust to the large inflow of solution.
Thus, there is a need for a device that prevents a free-flow condition if the infusion set is not properly mounted in the pump or other regulating means.
It is an object of the present invention to provide a safety occluder for infusion sets which prevents an accidental free-flow condition.
It is another object of the present invention to provide an occluder which is simple to make and use.
It is another object of the present invention to provide such an occluder which is inexpensive and thus disposable.
It is still another object of the present invention to provide an adapter for use on an enteral feeding pump or other device using an infusion set which enables use of a pinch clip occluder to occlude fluid flow through the infusion set unless the infusion set is properly loaded.
It is still yet another object of the present invention to provide such an adapter which may be retrofitted on existing pumps to improve safety and prevent free-flow conditions.
The above and other objects of the invention are realized in a pinch clip occluder biased in an occluding position to prevent free-flow conditions. In one embodiment of a pinch clip occluder, the occluder includes a housing with a passage therethrough and a pinch clamp nestable in the housing. The pinch clamp includes arms which are typically biased in a closed position when no external force is acting thereon, but which may be moved into an open/nonoccluding position by movement of the clamp relative to the housing.
In another illustrated embodiment, the occluder includes a housing with a passage therethrough for receiving a delivery set. A plunger disposed along the housing is movable between two positions, one of which occludes flow through the delivery set and the other of which allows flow through the delivery set. To overcome the risk of a free-flow condition, the plunger is typically biased in an occluding position.
In accordance with one aspect of the invention, a biasing member, such as a spring, is disposed between the housing and part of the plunger or pinch clamp to bias the plunger or pinch clamp in a closed position until the infusion set is properly mounted in a flow regulating device, such as an enteral feeding pump.
In accordance with another aspect of the invention, the pump housing is configured to selectively receive the pinch clip occluder. When the infusion set is properly mounted on the enteral feeding pump, etc., the pinch clip occluder is placed in such a position that fluid flow is allowed through the infusion set. If the infusion set is not properly loaded or is removed or dislodged from the pump, the pinch clip occluder will terminate fluid flow through the infusion set and thereby prevent the free-flow of solution to the patient.